# K082079: Regen Collagen Scaffold (CS)

- Pathway: 510(k) (Traditional)
- Applicant: Regen Biologics, Inc.
- Decided: Dec 18, 2008 after 148 days
- Product code: OLC (Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K921895 (1992). 54 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2003) Summary page 1.
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant, DePuy Orthopaedics, Inc. (2000) Summary page 1.
- K982330: Depuy Orthotech Restore Orthobiologic Soft Tissue Implant, Depuy, Inc. (1998) Summary page 1.
- K050337: Sis Fistula Plug, Cook Biotech, Inc. (2005) Summary page 1.
- K031188: Orthomend, Tei Biosciences, Inc. (2003) Summary page 1.
- K051766: Orthomend, Tei Biosciences, Inc. (2005) Summary page 1.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.
- K992159: Surgisis Sling, Cook Biotech, Inc. (1999) Summary page 1.
- K034039: Sis Plastic Surgery Matrix, Cook Biotech, Inc. (2004) Summary page 1.
- K043259: Bioblanket Surgical Mesh, Kensey Nash Corp. (2005) Summary page 1.
- K041923: Bioblanket, Kensey Nash Corp. (2004) Summary page 1.
- K992556: Permacol, Tissue Science Laboratories, Plc (2000) Summary page 1.
- K013625: Permacol, Tissue Science Laboratories, Plc (2002) Summary page 1.
- K021056: Permacol, Tissue Science Laboratories, Plc (2002) Summary page 1.
- K043366: Permacol Surgical Implant, Tissue Science Laboratories, Plc (2004) Summary page 1.
- K050355: Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150, Tissue Science Laboratories, Plc (2005) Summary page 1.
- K024199: Immix Thin Film, Models: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP, Osteobiologics, Inc. (2003) Summary page 2.
- K032673: Immix Plastifilm, Osteobiologics, Inc. (2003) Summary page 2.
- K052830: Sportmesh, Artimplant AB (2006) Summary page 2.
- K014200: Optimesh, Spineology, Inc. (2003) Summary page 2.
- K042809: Cuffpatch, Organogenesis, Inc. (2004) Summary page 2.
- (no number) Marlex Mesh: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K974540: Sis Hernia Repair Device, Sentron Medical, Inc. (1998). Our reading of the summary gave K974540, FDA’s number for Sis Hernia Repair Device (Sentron Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Surgisis Mesh”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K170364: Collagen Meniscus Implant XL (2017), 1 descendant of its own
- K242302: RejuvaKnee™ Collagen Meniscus Implant (2024), 0 descendants of its own

## Indications for use
The ReGen Collagen Scaffold (CS) Is intended for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization. The CS reinforces soft tissue and provides a resorbabkescaffold that is replaced by the patient's own soft tissue. The CS is not a prosthetic device and is not intended to replace normal body structure.

Source page: https://510kreport.com/device/K082079
Methodology: https://510kreport.com/methodology